The Federal Food, Drug and Cosmetic Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body . . . for cleansing beautifying, promoting attractiveness, or altering the appearance.” (FD&C Act, 21 U.S.C. § 321(i)). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polish, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors and deodorants as well as any substance intended for use as a component of a cosmetic product. The European Union Directive (76/768/EEC) defines a “cosmetic product” as “any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odors.” (Art. 1.1).
Cosmetic preservatives may be defined as a chemical or substance that is added to cosmetics to prevent decomposition by microbial growth or by undesirable chemical changes, e.g., oxidation. According to the US FDA, some of the ways cosmetics may become contaminated with bacteria or fungi are: contaminated raw materials, water or other ingredients; poor manufacturing conditions; ingredients that encourage growth of microorganisms without an effective preservative system; packaging that does not protect a product adequately; poor shipping or storage conditions; and consumer use such as the need to dip fingers into the product. Thus, it is vital that contamination with pathogenic microorganisms be minimized or prevented entirely, and it is the elimination of such microorganisms that this patent application addresses.
Most cream-based products are marketed in lidded jars with instructions to gently apply a small amount to the face in an upward circular motion once or preferably twice daily. An example of this type of product is NuFinity All-In-One/Day & Night Anti-Ageing Treatment (NuFinity Naturals, San Antonio, Tex. 78258). It is evident from the NuFinity instructions for use that the product is intended to be removed from the jar by the finger(s), and no instructions are given to wash the hands or use sterile gloves or applicators during product application. In some products of this kind, small applicators are supplied by the manufacturer to remove the product from the jar instead of using fingers, but the sterility of these applicators may not have been validated.
Because such products can be contaminated with pathogenic microorganisms during manufacture or by pathogenic microorganisms residing on the fingers every time the product is used, it has long been judged necessary to include antimicrobial/antifungal preservative agents in cosmetic formulae—usually at least two such preservative compounds are included in ingredient lists, e.g., Methylparaben (an antibacterial) and Propylparaben (an antifungal) to prevent microbial contamination of the product and prevent or retard subsequent microorganism growth, thus helping to prevent potential skin or systemic infections. This problem is thought to be so serious by the US FDA that it will, beginning in December, 2016, post, on a quarterly basis, data extracted from cosmetic adverse event reports submitted to FDA by consumers and health care providers. From Jan. 1, 2004 through Sep. 30, 2016, 4,322 such reports were submitted to the FDA for cosmetic products.
In the United States, cosmetics must contain preservatives because the FDA requires that the products not be injurious to the user and because insurance companies would not cover products that are not preserved. Cosmetic products are not required to be sterile, but the main embodiment of the present invention is to provide sterile, single dose products and eliminate the need for preservatives. Surgical products commonly used in operating rooms, such as internally indicated surgical sutures, are delivered sterile (usually radiation, ethylene oxide or heat sterilized) in microbially impervious single-use packaging and do not contain preservatives that are unnecessary in sterile single use packages.
While parabens are “Generally Recognized As Safe” for cosmetic use by the US FDA, there have been reports of parabens causing weak estrogenic activity leading to decreased testosterone production in male rats associated with significant caudal epididymal sperm reserve and sperm concentration decreases and reduction in daily sperm production and efficiency (Oishi, et al., “Effects of Propyl Paraben on The Male Reproductive System,” Food and Chemical Toxicology, 40, 1807 (2002)). Other reports concerning the toxicity of preservatives include, e.g., “Preservatives and Fragrances in Selected Consumer-Available Cosmetics and Detergents” (Yazar, et al., Contact Dermatitis, 64, 265 (2011)), which discusses skin-sensitization; and “Decreased Sperm Number and Motile Activity of the F1 Offspring Maternally Exposed to Butyl Paraben”, (Kang, et al., J. Vet. Med. Sci., 64, 227 (2002)), which discusses the significant decrease in both the number of pups born alive and surviving for 20 days from mothers receiving injections of 200 mg/kg of butyl paraben as were the lower weights of testes, seminal vesicles and prostate glands of F1 male offspring. In summary, maternal exposures to butyl paraben have adverse effects on the male offspring but not on the reproductive organs of the female offspring. See also “Urinary Concentrations of Parabens and Serum Hormone Levels, Semen Quality Parameters, and Sperm DNA Damage” (Meeker, et al., Environmental Health Perspectives, 119.2, 252 (2011)). There are many more such reports, two of which are listed below, that further substantiate these problems: “Possible endocrine disrupting effects of parabens and their metabolites” (Boberg, et al., J. Reproductive Toxicology, 30 301 (2010)); and “Assessment of Principal Parabens Used in Cosmetics After Their Passage Through Human Epidermis-dermis Layers” (El Hussein, et al., Experimental Dermatology, 16, 830 (2007)).
A useful overview of the severity of the current preservative situation entitled, “Restrictions Ramp Up On Cosmetic Preservatives,” was authored by M. Reisch in the Nov. 28, 2016 issue of Chemical & Engineering News, pages 18-20. Reisch quotes the Chief Executive Officer of International Cosmetics & Regulatory Specialists as saying preservatives are meant “to keep cosmetics safe throughout their useful life from production until the last bit is used at the bottom of the jar.” She fears that, over time, bacteria will build up resistance to the diminishing number of preservative options now available and does not see alternatives such as single-use or aseptic packaging as realistic—both because of the additional cost and because of the increased packaging waste. Thus, an expert who is highly skilled in the art, clearly teaches away from claims in the instant invention involving terminally sterilized single dose packaging.
The above overview also indicates the perception of severity of preservative toxicity by a group named the Green Chemistry and Commerce Council (GC3) that is creating a monetary prize competition for novel preservative concepts to accelerate the commercialization of new, safe and effective preservative systems. Such new systems also are to be biodegradable, free of carcinogen and endocrine disruption concerns and not likely to build microbial resistance. Among the 17 contest supporters, those that agreed to be named include Beiersdorf, Dow Chemical, Johnson & Johnson, Lonza, Target and Walmart. Thus, a group of large companies teaches away from sterilization and believes the solution to preservative toxicity is best based on new preservative technologies rather than on the sterilization of single dose cosmetic products not containing any added preservatives, as exemplified in this patent application.
Swinwood, et al., “Treatment of Cosmetics Ingredients With Gamma Radiation: A Market Development View”, International J. of Radiation Applications and Instrumentation, Part C. Radiation Physics and Chemistry, 35, 369 (1990) focused on the use of gamma radiation for the reduction of microbial loads in certain cosmetic raw materials but did not consider or suggest the terminal sterilization of finished, packaged single dose cosmetic formulations. Swinwood's cosmetic products would still require preservative additives.
According to the Breast Cancer Fund, info@breastcancerfund.org, “In the U.S., major loopholes in federal law allow the cosmetics industry to put thousands of synthetic chemicals into personal care products, even if those chemicals are linked to cancer, infertility or birth defects.”
Several US patents, e.g., U.S. Pat. No. 5,920,075, U.S. Pat. No. 5,221,563, U.S. Pat. No. 5,495,236, 4,786,812, U.S. Pat. No. 5,029,252 and U.S. Pat. No. 5,466,289 have been granted claiming the use of ultraviolet sterilization devices. However, such devices and their use are not claimed in the instant patent application because ultraviolet radiation will not penetrate the surfaces of opaque, sealed packaging materials as does gamma or electron beam radiation or heat. To be effective, UV rays must touch the surface of the micro-organism and so these UV-generator patents are not relevant to this invention.
U.S. Pat. No. 8,501,091 describes methods for heat sterilizing cosmetic products which comprise two different viscosities at two different regulated pressures and then aseptically cooling and packaging the combined product in a sterile atmosphere. A novel embodiment of the instant application discloses terminal thermal steam sterilization under pressure (autoclaving) and cooling in a sealed package.
A company in France, Pierre Fabre Laboratories, developed what they termed “Sterile Cosmetics” in 1996 and describes their production process in a company brochure as follows:
A. Sterilization of all cosmetic production equipment
B. Control of selected raw materials
C. Production of the cosmetic in a sterilized mixer (not a sterilizer mixer)
D. Innovative sterilization methods (not disclosed)
E. Packaging in a class A sterile environment
F. Training of production staff (sterile production requires specific expertise).
It is clear from this description that Pierre Fabre's products are manufactured and packaged aseptically and are not terminally sterilized in sealed packages by heat or by ionizing radiation exposure. Simply sterilizing mixing equipment does not necessarily sterilize cosmetic components being mixed in such equipment.
Using the Pierre Fabre process, a French company, Avene Dermatological Laboratories, marketed the first line of what was termed a “sterile” cosmetic product. Pierre Fabre also developed DEFI (Extreme Intact Formula Device), “ . . . making it possible to protect sterile medicines from all germs in a large-capacity tube; the product remains sterile throughout use, with no risk of bacterial contamination.” In 2009, two products were introduced by Avene in 50 ml DEFI tubes, clearly not single dose units. In 2011, a pediatric skin care product was launched by Avene in 50 ml DEFI tubes, and, in 2012, Avene launched two DEFI-based 50 ml products and that year, two 50 ml DEFI tube products were launched by A-Derma Dermatological Laboratories.
Thus, the direction taken to provide “sterile” cosmetics was to utilize the 50 ml DEFI multiple dose dispensing tubes. From Pierre Fabre Laboratories' publications, it is evident they did not consider combining single dose packaging with terminal radiation or other sterilization methods of single dose packaged cosmetics. Pierre Fabre Laboratories brochure goes on to state:
A. “The DEFI system helps preserve a completely intact sterile formula protected from all germs throughout the products use”
B. “No retro-contamination of the formula”
C. “Guaranteed sterile formula throughout entire use of the product.”
Clearly, Pierre Fabre products are aseptically prepared and packaged without terminal sterilization.
A 50 ml. tube of AVENE Sterile Eau Thermale Skin Recovery Cream for hypersensitive and irritable skin containing 0% preservative, 0% fragrance and 0% alcohol was purchased with instructions to apply morning and evening (Laboratoires Dermatologiques Avene, 45, place Abel-Gance, 92100 Boulogne, Paris-France). The package has a flat, circular plastic surface about 1.25 inches in diameter at the center of which is an orifice about 1/16 inch in diameter through which the reportedly sterile product is expelled by squeezing the attached 50 ml. tube. The user wipes the expelled product from the circular surface of the package, which leaves a thin, unpreserved layer of product exposed to viable bacteria until the next application, which transfers the contaminated product together with the next application. During this period, the sterile product containing no preservative or alcohol will be a site of bacterial proliferation. While the product in the tube is protected from contamination by a proprietary, unidirectional exit valve, it is contaminated by multi-hour exposure on the flat, circular plastic surface.
With the widespread use of anti-microbial preservatives such as, e.g., the parabens and chlorohexidine in cosmetic and cosmeceutical (i.e., formulations having drug-like effects or claims but not requiring FDA approval or clearance) formulations, it is evident that microbial (bacterial and fungal) contamination is an important issue and, because of potential adverse effects of such materials on the body as described in the literature cited above, it would be of advantage to safely eliminate their inclusion in cosmetics entirely.
Another disadvantage of manually dispensing an agent from a container such as a jar is that the actual optimum dose may not be accurately dispensed each time, depending upon the amount of product digitally transferred from the jar by a single individual from time to time or differences in amounts of the same material dispensed by different individuals.
The long felt need for cosmetic products with improved safety profiles is highlighted by the following report in Chemical & Engineering News, May 1, 2017, page 14: “Prize money available for new preservatives ($175,000) with improved environmental health and safety profiles for use in personal care and household products. The contest, operated by InnoCentive and the Green Chemistry & Commerce Council, is sponsored by Proctor & Gamble, Johnson & Johnson, and other firms. They are seeking broad-spectrum or single-action agents that control Gram-positive bacteria, Gram-negative bacteria, yeast, and mold or that act as preservative boosters. View contest details on line at . . . ”
The present invention addresses the need for cosmetic products that are free of preservatives and at the same time, safe, sterile and convenient to use.
The disclosures of the publications mentioned herein are hereby incorporated by reference in their entireties into the subject application to more fully describe the art to which the subject application pertains.